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Showing 1–24 of 47 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
Completed Phase 3 Interventional Results available

Fontan Udenafil Exercise Longitudinal Assessment Trial

NCT02741115
Conditions
Single Ventricle Heart Disease
Interventions
Udenafil, Placebo
Drug
Lead sponsor
Mezzion Pharma Co. Ltd
Industry
Eligibility
12 Years to 18 Years
Enrollment
400 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
26
States / cities
Phoenix, Arizona • Los Angeles, California • San Diego, California + 22 more
Completed Not applicable Interventional

Re-Energize Fontan

NCT04195451
Conditions
Single-ventricle
Interventions
Live-Video-Supervised Exercise Intervention, Usual Care then Live-Video Supervised Exercise Intervention
Other
Lead sponsor
Stanford University
Other
Eligibility
8 Years to 19 Years
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2026
U.S. locations
1
States / cities
Palo Alto, California
Completed Phase 3 Interventional Results available

A Extension Study of Udenafil in Adolescents

NCT03013751
Conditions
Functional Single Ventricle Heart Disease
Interventions
Udenafil
Drug
Lead sponsor
Mezzion Pharma Co. Ltd
Industry
Eligibility
12 Years to 18 Years
Enrollment
301 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
21
States / cities
Phoenix, Arizona • Los Angeles, California • San Diego, California + 18 more
Terminated Phase 2Phase 3 Interventional Results available

Colchicine in Postoperative Fontan Patients

NCT03575572
Conditions
Single-ventricle, Heart Diseases
Interventions
Colchicine
Drug
Lead sponsor
University of Michigan
Other
Eligibility
20 Months to 5 Years
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
1
States / cities
Ann Arbor, Michigan
Completed No phase listed Observational

Fontan Imaging Biomarkers (FIB) Study

NCT03119090
Conditions
Single-ventricle, Congenital Heart Disease
Interventions
Not listed
Lead sponsor
Boston Children's Hospital
Other
Eligibility
3 Years and older
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2021
U.S. locations
1
States / cities
Boston, Massachusetts
Conditions
Fontan Circulation
Interventions
Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg), Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years)
Drug
Lead sponsor
Children's Mercy Hospital Kansas City
Other
Eligibility
8 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
1
States / cities
Kansas City, Missouri
Conditions
Single Ventricle Fontan Palliation
Interventions
Ambrisentan
Drug
Lead sponsor
Washington University School of Medicine
Other
Eligibility
18 Years to 50 Years
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
1
States / cities
St Louis, Missouri
Conditions
Single-ventricle, Stenosis
Interventions
Cardiopulmonary Exercise Testing (CPET), Shear Wave Elastography Scan
Diagnostic Test
Lead sponsor
Children's Hospital Los Angeles
Other
Eligibility
12 Years to 21 Years
Enrollment
20 participants
Timeline
2025 – 2027
U.S. locations
1
States / cities
Los Angeles, California
Conditions
Heart Failure Congenital, Single-ventricle
Interventions
Cardiac rehabilitation, Usual care
Behavioral · Other
Lead sponsor
Stanford University
Other
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
2
States / cities
Stanford, California • Nashville, Tennessee
Conditions
Single-ventricle, Hepatic Congestion
Interventions
Fenestration status
Other
Lead sponsor
Boston Children's Hospital
Other
Eligibility
Not listed
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2022
U.S. locations
1
States / cities
Boston, Massachusetts
Conditions
Dopamine, Protein-Losing Enteropathies, Lymphatic System, Lymph, Catecholamine, Single-ventricle, Congenital Heart Disease
Interventions
Not listed
Lead sponsor
University of Michigan
Other
Eligibility
3 Years and older
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2026
U.S. locations
1
States / cities
Ann Arbor, Michigan
Conditions
Tetralogy of Fallot, Transposition of the Great Vessels With an Arterial Switch, Single Ventricle With a Fontan Palliation
Interventions
Eplerenone
Drug
Lead sponsor
Washington University School of Medicine
Other
Eligibility
18 Years to 80 Years
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
1
States / cities
St Louis, Missouri
Conditions
Fontan Procedure, Hypoplastic Left Heart Syndrome, Tricuspid Atresia
Interventions
Vitamin C, Placebo
Dietary Supplement
Lead sponsor
University of Michigan
Other
Eligibility
8 Years to 25 Years
Enrollment
53 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009 – 2010
U.S. locations
1
States / cities
Ann Arbor, Michigan
Recruiting Not applicable Interventional

Fontan Fitness Trial

NCT06918795
Conditions
Single-ventricle, Congenital Heart Disease
Interventions
Digital Exercise Intervention
Behavioral
Lead sponsor
Children's Hospital of Philadelphia
Other
Eligibility
10 Years to 17 Years
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Conditions
Congenital Disorders
Interventions
Not listed
Lead sponsor
Children's Healthcare of Atlanta
Other
Eligibility
Up to 18 Years
Enrollment
400 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1990 – 2007
U.S. locations
1
States / cities
Atlanta, Georgia
Conditions
Single Ventricle, Fontan
Interventions
Carvedilol, Placebo
Drug
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
10 Years to 35 Years
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
1
States / cities
Dallas, Texas
Conditions
Fontan Procedure, Hypoplastic Left Heart Syndrome, Tricuspid Atresia, Double Inlet Left Ventricle
Interventions
Not listed
Lead sponsor
University of California, San Francisco
Other
Eligibility
10 Years and older
Enrollment
13 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009 – 2012
U.S. locations
1
States / cities
San Francisco, California
Conditions
Congenital Heart Disease With Fontan Circulation
Interventions
macitentan 10 mg
Drug
Lead sponsor
Actelion
Industry
Eligibility
12 Years and older
Enrollment
112 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
2
States / cities
Boston, Massachusetts • Spokane, Washington
Completed Phase 1Phase 2 Interventional Results available

Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents

NCT02201342
Conditions
Single Ventricle Heart Disease After Fontan Surgery
Interventions
Udenafil
Drug
Lead sponsor
Mezzion Pharma Co. Ltd
Industry
Eligibility
14 Years to 18 Years
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
5
States / cities
Indianapolis, Indiana • Ann Arbor, Michigan • Cincinnati, Ohio + 2 more
Conditions
Congenital Heart Disease, SRV Dependent
Interventions
Autologous mononuclear cells
Biological
Lead sponsor
Timothy J Nelson, MD, PhD
Other
Eligibility
2 Years to 5 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
6
States / cities
Birmingham, Alabama • Los Angeles, California • Aurora, Colorado + 3 more
Conditions
Fontan Physiology Patients With PB or PLE, Fontan Physiology Patients Without PB or PLE
Interventions
Not listed
Lead sponsor
Medical College of Wisconsin
Other
Eligibility
6 Months and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2013
U.S. locations
1
States / cities
Milwaukee, Wisconsin
Conditions
Single Ventricle Defect
Interventions
Not listed
Lead sponsor
Children's Hospital of Philadelphia
Other
Eligibility
4 Months to 10 Years
Enrollment
260 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2016
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Not yet recruiting No phase listed Observational

Occlutech AFR Fontan Study

NCT07532369
Conditions
Failure of Fontan Type Circulation, Fenestration, Univentricular Heart, Congenital Anomaly
Interventions
Occlutech Atrial Flow Regulator Retrospective Data Collection
Device
Lead sponsor
Occlutech International AB
Industry
Eligibility
Not listed
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026
U.S. locations
7
States / cities
Birmingham, Alabama • Los Angeles, California • San Diego, California + 4 more
Conditions
Adult Congenital Heart Disease, Congenital Heart Disease, Systemic Right Ventricle, Transposition of the Great Arteries, Congenitally Corrected Transposition of the Great Arteries, Fontan, Single Ventricle, Tetralogy of Fallot (TOF)
Interventions
SGLT2 inhibitors
Drug
Lead sponsor
Leiden University Medical Center
Other
Eligibility
18 Years and older
Enrollment
400 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
3
States / cities
Baltimore, Maryland • Grand Rapids, Michigan • New York, New York